Wound barrier pad

ABSTRACT

A wound barrier pad is provided having a housing with a housing opening. The housing has a truncated conical shape. A base plate with an opening is disposed in the housing, and the housing is filled with a fluid or padding. The wound barrier pad may also be embodied to have a cylindrical shape, a rectangular shape or other shape. The wound barrier pad may be incorporated into a garment. In another embodiment the wound barrier pad includes a ring and an adhesive such that the wound barrier pad may be directly adhered to the patient, thus eliminating the need for the garment. In another embodiment there is a wound barrier device having a pad assembly and an anti-sheer member. The anti-shear member reduces frictional forces on the skin of a patient. In another embodiment a wound barrier assembly is provided for applying a negative pressure to a wound.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation in part of U.S. patentapplication Ser. No. 13/560,126, filed on Jul. 27, 2012, now U.S. Pat.No. 9,237,969, that in turn claims priority to U.S. Provisionalapplication having Application No. 61/512,470, filed on Jul. 28, 2011,the entire disclosures and contents of each of which are herebyincorporated herein by reference.

BACKGROUND

Many patients with mobility issues have a limited ability to changepositions. These individuals are at an increased risk of developingpressure ulcers, also called pressure sores or bedsores. These patientsare often confined to a wheelchair or are confined to their beds forprolonged periods of time. As a result, such patients put an incredibleamount of constant pressure or shear force on the same location of thebody. When the same location on the body withstands constant pressure orshear force, a pressure ulcer can develop in that location. A pressureulcer is an injury to the skin and the underlying tissues. Pressureulcers typically develop on skin that covers bony areas of the body,such as the heel, ankles, hips, or buttocks.

Pressure ulcers are increasing in frequency among a diverse population.In particular, at risk are elderly patients with neurologicalabnormalities, patients with diabetes mellitus, and patients withdementia or other mental illnesses. Many of these patients are unable tomove around and adjust themselves properly, so a family member, a nurseor other medical attendant is required to assist them at predeterminedintervals. In some cases, the family member, the nurse or medicalattendant is not available to assist with adjusting the patient's bodyposition. Without assistance, the patient will remain in the sameposition increasing the likelihood of developing pressure ulcers.

There are four stages of pressure ulcers, depending on the depth of thewound and the level of tissue involvement. Stage 1 involves erythema andedema of the skin. Stage 2 involves a partial loss of skin thickness,which may include a loss of the epidermis, dermis, or both. The lesionis superficial and appears as an abrasion, blister, or shallow ulcer.Stage 3 involves a complete loss of skin thickness and includes damageor necrosis of subcutaneous tissue that may extend down to theunderlying fascia. The pressure ulcer will appear as a deep crater withor without damage to the adjacent tissues. Stage 4 is the worst stage,whereby the pressure ulcer exposes the underlying tissue includingtendons, bones, and ligaments.

The morbidity and mortality associated with pressure ulcers is wellknown. Medicare and other health insurance providers often recognizepressure ulcers as a complication of hospitalization. As such, thehealth insurance providers are monitoring pressure ulcer rates moreclosely and are increasingly less likely to reimburse the costs oftreating pressure ulcers that occur in a hospital setting. Additionally,long-term care facilities and nursing homes have been scrutinized formany years at both the state and federal level, with attention tocomplications such as pressure ulcers.

Treatment of pressure ulcers typically includes surgical debridement,treatment with antibiotics, negative pressure dressings, andmodification of the underlying skin deficit. In order for the treatmentto be successful, it is paramount that the pressure and shear force onthe pressure ulcer be minimized. This is typically done by repositioningthe patient, using a “shifting” mattress, or by use of barrierdressings.

These are also the same means used to prevent the pressure ulcer fromdeveloping. Thus, if these means weren't sufficient to prevent apressure ulcer, they may prove ineffective at treating the pressureulcer. As part of the treatment for pressure ulcers, it is imperativethat the pressure ulcer is not subjected to pressure or shearing forces.Because of the typical location of the pressure ulcer (pelvic area,lower area, tail bone, hip), it is often extremely difficult to preventany pressure or shear forces from being placed on the pressure ulcer.This is especially true given that it may take several months to heal apressure ulcer.

To date, there has not been any treatment that effectively protects thepressure ulcer from pressure and shear effects.

SUMMARY

A wound barrier pad comprising a housing having opposed first and secondwalls, a surrounding wall extending from the first wall to the secondwall, and a surrounding internal wall extending from the first wall tothe second wall wherein the surrounding internal wall defines a housingopening. A housing interior is defined by the opposing first and secondwalls, the surrounding wall, and the surrounding internal wall. A baseplate disposed in the housing and is supported on the first wall. Thehousing interior is filled with padding. The padding is a resilientpadding, foam or can be replaced with or used in combination with afluid.

The housing may have a truncated conical shape, a cylindrical shape, arectangular shape or other suitable shape. An adhesive can be applied tothe second wall of the housing to adhere the wound barrier pad to thepatient or user.

The wound barrier pad is incorporated into a garment in one of thepreferred embodiments. In use, the wound barrier pad is fitted in apocket of the garment and positioned over the wound and bandages, suchthat the opening in the housing surrounds the wound. The garment holdsthe wound barrier pad in place such that the wound barrier pad remainsin a fixed location relative to the wound.

The wound barrier pad absorbs shearing and pressure forces that aregenerated as the patient (or user of the wound barrier pad) moves or ismoved. For example, when the patient moves while he or she is sleepingor when the patient is moved in a mechanical bed having an air mattress.This is very helpful in the treatment and prevention of wounds such asbedsores, burns and incisions.

In another preferred embodiment the wound barrier pad includes a ringwith adhesive applied to the opposed sides of the ring. The adhesive maybe in the form of a layer of adhesive. The adhesive joins the ring tothe wound barrier pad and the patient. This embodiment eliminates theneed for a garment to hold the wound barrier in place.

The wound barrier pad may have a truncated conical shape, a rectangularshape, a cylindrical shape, and may be made to have virtually asrequired for a particular application.

In another preferred embodiment there is a wound barrier device thatincludes an anti-shear pad having a pad assembly, and that includes ananti-shear member.

The pad assembly includes an outer layer, a cap, and a center memberthat defines a center member opening. The anti-shear member defines ananti-shear member opening. The anti-shear member is adhered to thecenter member of the pad assembly. A suitable wound dressing is providedand is fitted in the center member opening. The pad assembly furtherincludes a first adhesive. The outer layer is joined to the cap with thefirst adhesive, and the center member and the first member are joinedwith the first adhesive. There is a second adhesive that joins thecenter member of the pad assembly with the anti-shear member, and theanti-shear member has an anti-shear member opening. The center memberopening and the anti-shear member opening are axially aligned. The outerlayer and the center member are made of padding in one of the preferredembodiments.

The center member opening and the anti-shear member opening define a padpassage that extends to the cap. The cap is made of a stiff resilientplastic in one of the preferred embodiments. And, the cap is movablefrom a relaxed cap position to a flexed cap position.

The outer layer outer layer, the cap, and the center member of the padassembly are joined together to form the anti-shear pad, and theanti-shear pad is movable from an anti-shear pad un-flexed position toan anti-shear pad flexed position. When the pad assembly is in theflexed position the outer layer, the cap, and the center member areconvex, as is the anti-shear member joined to the center member.

When the anti-shear pad is in the anti-shear pad flexed position the capgenerates a biasing force that is applied to the center member. In oneof the preferred embodiments when the anti-shear pad is in theanti-shear pad flexed position it is fitted in the buttocks (of apatient) such that the cap applies a force to the buttocks in order toseparate the buttocks. The anti-shear member joined to the anti-shearpad abuts against the skin when the anti-shear pad is so positioned.

The wound barrier pad can be sold as a kit comprising wound barrier padsand wound barrier devices having different three-dimensional shapes.

In another preferred embodiment the wound barrier pads and the woundbarrier device are part of a wound care apparatus.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 is a front elevational view of a wound barrier pad.

FIG. 2 is a top plan view of the wound barrier pad.

FIG. 3 is a top plan view of a base plate for use in the wound barrierpad.

FIG. 4 is a sectional view of the wound barrier pad taken along line A-Aof FIG. 1.

FIG. 5 is a front elevational view of a second embodiment showing awound barrier pad wherein the wound barrier pad is rectangular shaped.

FIG. 6 is a top plan view of the second embodiment of the wound barrierpad.

FIG. 7 is a sectional view of the rectangular shaped wound barrier padtaken along line B-B of FIG. 6.

FIG. 8 is a top plan view of a garment with a wound barrier padinstalled therein.

FIG. 9 is a sectional view taken along line C-C of FIG. 8 wherein thewound barrier pad is fitted in the garment.

FIG. 10 is a front elevational view of a wound barrier pad and a ringthat is moved into contact with the wound barrier pad as indicated bythe arrow designated A.

FIG. 11 is a top plan view of the ring.

FIG. 12 is a sectional view of the wound barrier pad and the ring takenalong line D-D of FIG. 10 after the ring has been joined to the woundbarrier pad.

FIG. 13 is a sectional view of the wound barrier and ring adhered to apatient.

FIG. 14 is an exploded view of another embodiment showing a woundbarrier device.

FIG. 14A is a front view of the wound barrier device when assembled.

FIG. 15 is a top plan view of an outer layer.

FIG. 16 is a top plan view of a top plan view of a cap in a relaxed capposition.

FIG. 16A is a top plan view of a top plan view of a cap in a flexed capposition.

FIG. 17 is a top plan view of a center member.

FIG. 18 is a top plan view of a dressing for a wound.

FIG. 19 is a top plan view of an anti-shear member.

FIG. 19a depicts an anti-shear member as flexible plastic bladder.

FIG. 19b depicts the anti-shear member as a breathable foam pad.

FIG. 20 is a top plan view of a pad assembly of an anti-shear pad.

FIG. 21 is a bottom plan view of the pad assembly of the anti-shear pad.

FIG. 22 is a top plan view of an anti-shear pad when in an anti-shearpad flexed position and joined to an anti-shear member.

FIG. 23 is a left side elevational view of the anti-shear pad when inthe anti-shear pad flexed position and joined to the anti-shear member.

FIG. 24 is a rear elevational view of the anti-shear pad when in theanti-shear pad flexed position and joined to the anti-shear member.

FIG. 25 is a rear view of a patient having a wound.

FIG. 26 is a rear view of the patient after application of the woundbarrier device.

FIG. 27 is a plan view of a kit.

FIG. 28 is a front view of a negative pressure wound treatment device.

FIG. 29 is a front elevational view of a drape.

FIG. 30 is a top view of the drape.

FIG. 31 is a top view of a negative pressure dressing.

FIG. 32 is a front view of the negative pressure dressing.

FIG. 33 is diagrammatic view of a wound treatment assembly that includesthe rectangular shaped wound barrier pad shown in FIGS. 6 and 7 and thenegative pressure treatment device.

FIG. 34 is a front view of an alternative embodiment of FIG. 33 whereinthe suction tube passes through the rectangular shaped wound barrierpad.

FIG. 35 is a top plan view of the suction tubes extending over andpassing through the rectangular shaped wound barrier pad.

FIG. 36 is a rear view of the patient after application of the drapeshowing the drape and the wound barrier device.

FIG. 36A is a wound barrier device component of the wound careapparatus.

DETAILED DESCRIPTION

It is pointed out at the outset that like reference numbers are usedthroughout this description to signify common elements, components,surfaces, parts and features.

A wound barrier pad 20 is shown in FIGS. 1 and 2. The wound barrier pad20 has a housing 22 having a first wall 24, an opposed second wall 26,and a surrounding exterior wall 28 that is joined to the first andsecond walls 24, 26. The opposed first and second walls 22, 24 aresubstantially flat. The housing 22 also has a surrounding internal wall30 that is joined to the first and second walls 24, 26. As shown inFIGS. 2 and 4, the surrounding internal wall 30 defines a housingopening 32 in the housing 22. The opposed first and second walls 22, 24,the surrounding exterior wall 28 and the surrounding internal wall 30define a housing interior 23. As shown in FIG. 2, the housing opening 32has a housing opening diameter designated D3. The surrounding exteriorand internal walls 28, 30 are each curved in one of the preferredembodiments. The housing 22 may be made of woven and nonwoven fabrics,natural or synthetic fabrics, rubber, plastics, suitable flexiblematerials, and combinations thereof.

The diameter of the first wall 24, designated D1 in FIG. 2, is greaterthan the diameter of the second wall 26, designated D2 in FIG. 2. Thus,the surrounding exterior wall 28 has a substantially truncated conicalshape 34 such that the wound barrier pad 20 has a truncated conicalshape. It is pointed out that a distance designated D in FIG. 1indicates the distance from the first wall 24 to the second wall 26 maybe varied to be any distance required for a particular application.

As shown in FIG. 3 the wound barrier pad 20 also has a base plate 36that is disposed in the housing interior 23 in one of the preferredembodiments. The base plate 36 is supported on the first wall 24 of thehousing 22 as shown in FIG. 4 and abuts against the first wall 24 in oneof the preferred embodiments. The base plate 36 has a base platediameter designated D4 in FIG. 3 that is less that the diameter D1 ofthe first wall 24 of the housing 22. The base plate 36 is circularshaped and defines a base plate opening 38 having a diameter designatedD5 in FIG. 3. The diameter D5 of the base plate opening 38 is less thanthe diameter D3 of the housing opening 32. The base plate 36 maycomprise any suitable material that will not create pressure points whenthe patient 82 or consumer is using the wound barrier pad 20. The baseplate 36 is therefore made of a flexible material, for example plastic,flexible plastic, woven fabrics, flexible fabrics, and other suitablematerials.

FIG. 4 is a view taken along line A-A of FIG. 1. As shown, disposedinternal to the housing 22 is padding 40. In one of the preferredembodiments, the padding 40 may be in the form of a body of padding 42having a shape that mimics the shape of the housing 22. That is, thebody of padding 42 has a truncated conical shape 44. The padding 40 maycomprise resilient materials, foams, neoprene, resilient foams thatreturn to their original shape after having been deformed, or any othersuitable resilient material.

It is pointed out that the wound barrier pad 20, for example the housing22, the padding 40 the base plate 36 can all be embodied such that theyare impregnated with silver, for example silver particles which mayprevent deleterious bacterial growth. The same is true for all theembodiments to be described below.

As previously mentioned, the surrounding exterior wall 28 has asubstantially truncated conical shape 34. This shape provides for moreeven load distribution when the first wall 24 applies pressure on apatient 82 or user of the wound barrier pad 20 as will be describedpresently. In another preferred embodiment the padding 40 is replacedwith a fluid 43. The fluid 43 can have a low viscosity in one of thepreferred embodiments. The fluid 43 provides for even load distributionwhen the wound barrier pad 20 is in use. The fluid 43 in combinationwith the housing 22 behave in a manner similar to a memory pad in thatthe fluid 43 causes the housing 22 to return to its original truncatedconical shape after having been deformed.

In other preferred embodiments, the diameter D1 of the first wall 24 isthe same as the diameter D2 of the second wall 26. In such an embodimentthe wound barrier pad 20 would have a substantially cylindrical shape ascompared to the truncated conical shape described above.

In another preferred embodiment the above-described base plate 36 isabsent.

FIGS. 5-7 show another preferred embodiment wherein a rectangular shapedwound barrier pad 50 is provided. The rectangular shaped wound barrierpad 50 has a rectangular housing 52 with opposed first and second endwalls 56, 58, that are joined to a pair of opposed third and fourth endwalls 60, 62. A first open wall 64 that defines a first wall opening 65is joined to the first, second, third, and fourth end walls 56, 58, 60,62, and an opposed second open wall 66 that defines a second wallopening 67 is joined to the first, second, third, and fourth end walls56, 58, 60, 62. The first, second, third, and fourth end walls 56, 58,60, 62, and the first and second open wall 64, 66 can be made of thesame materials as described in connection with housing 22 describedabove.

The rectangular housing 52 also has a rectangular shaped internal wall68 that is joined to the first and second open walls 64, 66. Therectangular shaped internal wall 68 defines a rectangle shaped housingopening 70 in the rectangular housing 52. The rectangular housingdefines a rectangular shaped housing interior 53. As shown in FIG. 7,the rectangular shaped wound barrier pad 50 also has a rectangularshaped base plate 72 that is disposed internal to the rectangularhousing 52 and is supported on the first open wall 64. The rectangularshaped base plate 72 defines a shaped base plate opening 74. Therectangular shaped base plate 72 is sized and shaped such that it issupported on the first open wall 64 and in one of the preferredembodiments abuts against the first open wall 64. The rectangular shapedbase plate 72 can be made of the same materials described above inconnection with the base plate 36.

FIG. 7 is a view taken along line B-B of FIG. 6. As shown, disposedinternal to the rectangular housing 52 is padding 40. In one of thepreferred embodiments, the padding 40 may be in the form of arectangular body of padding 76 having a shape that mimics the shape ofthe rectangular housing 52 and sized so as be received therein. That is,the rectangular body of padding 76 has a shape substantially identicalto the shapes shown in FIGS. 5 and 6. The padding 40 may also be in theform of the previously described fluid.

It is to be understood that while truncated conical shaped, cylindricalshaped, and rectangular shaped wound barrier pads have been described,the wound barrier pad may have virtually any geometry as required for aparticular application. For example, the wound barrier pad may betriangular shaped, octagonal shaped, star shaped, ellipse shaped, and soon. All of these embodiments are within the scope of this invention.

FIGS. 8 and 9 show the wound barrier pad 20 installed in a garment 80and being worn by a user or patient 82, with FIG. 9 being a sectionalview taken along line C-C of FIG. 8. As shown, the patient 82 has abandage or dressing 84 covering a wound 86. The dressing 84 and wound 86are not in contact with the wound barrier pad 20. The wound may be abedsore, a burn, a skin ulcer, a surgical incision, or other wound. Thegarment 80 has a pocket 88 for accommodating the wound barrier pad 20.The pocket 88 is joined to the garment 80 with a connector component 90joined to the garment 80. The connector component 90 may be a hook andloop type fastener, a releasable adhesive or other suitable fastener sothat the wound barrier pad 20 may be installed or removed for cleaningor replacement and the garment 80 can be washed and reused. In anotherpreferred embodiment the pocket 88 is a built-in pocket and theconnector component 90 may be in the form of a stitched seam. Thegarment 80 may be made out of a compressive elastic material, forexample nylon or spandex and combinations.

One of the advantages of the wound barrier pad 20 is that it isolatesthe wound 86 from pressure and shearing forces that are generated by thepatient 82 as he or she moves (twists, turns, rolls), for example whilesleeping. The wound barrier pad 20 also protects wound 86 of the patient82 from pressure and shearing forces while the patient 82 is being movedby his or her healthcare providers. And, the wound barrier pad 20protects the patient 82 from pressure and shearing forces while he orshe is being moved by a mechanical device, for example while resting inan inflatable bed or mattress or on a mechanical bed.

FIGS. 10-13 show another preferred embodiment wherein the wound barrierpad 20 is releaseably attached to the patient 82. The wound barrier pad20 is structurally the same as previously described wound barrier pad 20shown in FIGS. 1-4.

As shown in FIG. 11, a ring 100 that defines a ring opening 102 isprovided. The ring opening 102 has a diameter that is substantially thesame as the housing opening diameter D3. The ring 100 is made ofsilicone in one of the preferred embodiments. The ring 100 has opposedfirst and second ring sides 104, 106, an outer edge 108 and an inneredge 110. The inner edge 110 defines the ring opening 102. The first andsecond ring sides 104, 106 each have an adhesive 112 disposed thereon,and the adhesive may be in the form of a layer of adhesive 114 in one ofthe preferred embodiments. The ring 102 may be cut from a commerciallyavailable sheet of silicone and coated with a suitable medical gradeadhesive 112. The use of silicone sheets and suitable adhesives for usein connection with silicone sheets is well known to those havingordinary skill in the art and is therefore not described in greaterdetail herein.

As shown in FIG. 10, the ring 100 is moved in the direction of the arrowdesignated A and adhered to the first wall 24 of the wound barrier pad20. FIG. 12 is a sectional view taken along line D-D of FIG. 10 showingthe ring 100 after it has been adhered to the wound barrier pad 20. FIG.13 shows a sectional view of the wound barrier pad 20 and ring 100 afterhaving been adhered to a patient 82. The wound barrier pad 20 isolatesthe wound 86 from pressure and shearing forces that are generated by thepatient 82 as he or she moves (twists, turns, rolls), for example whilesleeping. The wound barrier pad 20 also protects the patient 82 frompressure and shearing forces when being moved by healthcare providers.And, the wound barrier pad 20 protects the patient 82 from pressure andshearing forces while he or she is being moved by a mechanical device,for example while resting in an inflatable bed or mattress.

It is pointed out that in another preferred embodiment the ring 100 maybe eliminated and the adhesive 112 may be directly applied to the firstwall 24 of the wound barrier pad 20 and adhered to the patient.

In another preferred embodiment shown in FIGS. 14-26 there is a woundbarrier device 199 that includes an anti-shear pad 200 having a padassembly 202, and includes an anti-shear member 270. The wound barrierdevice 199 is, in one of the preferred embodiments, used for padding andprotecting the skin 83 of the patient 82, for example, the skin thatoverlies the sacral bone of the patient 82 (see FIG. 25), it beingunderstood that the wound barrier device 199 is capable of being used inother applications. A minimal amount of body tissue, and thus naturalcushioning, exists between the sacral bone and the skin 83 that overliesthe sacral bone. Coupled with the great pressures to which the skin 83overlying the sacral bone is exposed makes this skin 83 subject toserious ulcer based wounds 86. In addition, the buttocks 85 of thepatient 82 also make it quite difficult to effectively treat wounds 86that form in the skin overlying the sacral bone because of the deeprecess formed by the buttocks 85. Indeed, when just a standardcommercially available bandage is applied over a wound 86 in the skinoverlying the sacral bone and between the buttocks 85, the standardbandage can and will have a deleterious effect on the wound 86 due tothe significant frictional forces the standard bandage imparts in thevicinity of the ulcer or wound 86.

Turning now to the exploded view of FIG. 14, shown therein is a woundbarrier device 199 that includes an anti-shear pad 200 having a padassembly 202, and includes an anti-shear member 270. FIG. 14A shows theassembled wound barrier device 199.

The pad assembly 202 has a layered structure and includes an outer layer210 that has opposed first and second outer layer surfaces 214, 216spaced from one another by a surrounding surface 218. In one of thepreferred embodiments the outer layer 210 is made of the above describedpadding 40 that comprises resilient materials, foams, neoprene,resilient foams that return to their original shape after having beendeformed, or any other suitable resilient material. Again, the paddingcan be impregnated with silver. The shape of the outer layer 210 iscylindrical as shown in FIG. 15 and can be embodied to have other shapesin other preferred embodiments.

The pad assembly 202 of the anti-shear pad 200 also includes a cap 220and the cap 220 is resiliently deformable between a relaxed cap position222 (shown in FIGS. 14 and 16) and a flexed cap position 224 (shown inFIG. 16A). The cap 220 is made of plastic in one of the preferredembodiments and the cap 220 can define perforations in one of thepreferred embodiments for airflow and for controlling the degree ofresilience of the cap 220. The cap 220 has opposed first and second capsurfaces 221, 223 and a surrounding cap surface 225 extends from thefirst cap surface 221 to the second cap surface 223. The first capsurface 221 is joined to the second outer layer surface 216 of the outerlayer 210 with a first adhesive 112 a when the cap 220 is in the relaxedposition 222. The first adhesive 112 a may be directly applied in theform of a coating or a spray or may be embodied as an adhesive layerwherein the opposed sides of the adhesive layer are sticky and coveredby removable non-stick cover sheets prior to use. Adhesives and coversheets for use on adhesives are well known to those having ordinaryskill in the art and are therefore not described in greater detailherein.

As shown in FIGS. 14 and 17, the pad assembly 202 of the anti-sheer pad200 also includes a center member 226. The center member 226 has a firstcenter member surface 230 and an opposed and second center membersurface 232 that are spaced from one another by a center membersurrounding surface 234. Each of the first center member surface 230 andsecond center member surface 232 meets with an internal surroundingsurface 227, and the internal surrounding surface 227 defines a centermember opening 228 in the center member 226. In one of the preferredembodiments the center member 226 is made of padding 40, and it can beimpregnated with silver particles. The first adhesive 112 a joins thesecond outer layer surface 216 of the outer layer 210 to the firstcenter member surface 230 of the center member 226. It is pointed outthat a central axis designated X in FIG. 14 extends axially through thecenter member opening 228.

After joining the outer layer 210 and the center member 226 the cap 220is held against the outer layer 210 and the center member 226 and iskept in place. The center member opening 228 leads to the cap 220 in oneof the preferred embodiments. In another preferred embodiment the cap220 can be embodied to define a cap opening that is aligned with thecenter member opening 228.

The arrows designate T in FIG. 14 indicate the direction theabove-described outer layer 210, cap 220, center member 226 and firstadhesive 112 a are brought together for form the pad assembly 202 of theanti-shear pad 200. It is pointed out that the cap 220 spans over thecenter member opening 228 and is disposed internal to the pad assembly202.

As shown in FIGS. 14 and 18, the pad assembly 202 is capable of housinga wound dressing 84. The wound dressing 84 can be embodied as cotton,fabrics, and other suitable dressings that are well known to thosehaving ordinary skill in the art. As shown in FIG. 14 wound dressing 84is disposed in the center member opening 228, and in one of thepreferred embodiment abuts against the internal surrounding surface 227of the center member 226. The wound dressing 84 extends beyond thesecond center member surface 232 of the center member 226 so as to beable to be in proximity or close proximity to the wound 86.

FIGS. 14, 19A and 19B show the anti-shear member 270 of the woundbarrier device 199. The anti-shear member 270 is joined to theanti-shear pad 200. In particular, a second adhesive 112 b adheres thesecond center member surface 232 of the center member 226 to theanti-shear member 270. The anti-shear member 270 has opposed first andsecond anti-shear member sides 272, 274 and a surrounding surface 278that extends from the first anti-shear surface 272 to the secondanti-shear surface 274. The anti-shear member 270 defines an anti-shearmember opening 276 that is axially aligned along a central axisdesignated X. The anti-shear member 270 is made of a low frictionplastic material.

In another preferred embodiment (FIG. 19A) the anti-shear member 270 isembodied as a flexible plastic bladder 300 made of a low frictionmaterial and filled with a fluid 302. The flexible plastic bladder 300has a leak-proof central bladder opening 304. The second adhesive 112 bjoins one of the sides 306 of the flexible plastic bladder 300 to thecenter member 226. Alternatively, an adhesive 112 can be applied to theone side 306 of the flexible plastic bladder 300 and covered with aremovable slip or cover sheet 309 that can be removed to expose anadhesive 112, in which case the second adhesive 112 b may not benecessary. The other side 308 of the flexible plastic bladder 300 is forabutting against the patient 82 in a manner such that the centralbladder opening 304 surrounds the wound.

In another preferred embodiment (FIG. 19B) the anti-shear member 270 isembodied as a breathable foam pad 320 having opposed first and secondbreathable sides 322, 322, and a breathable foam pad opening 340 isdefined in the breathable foam pad 320. The opposed first and secondbreathable sides 322, 324 are made of a low friction plastic materialhaving apertures 326, and a breathable foam 40 a is disposed betweenthem. The first and second breathable sides 322, 324 form a peripheraledge 328 that extends beyond and around the breathable foam 40 a. Oneside 329 of the peripheral edge 328 may be coated with an adhesive 112so as to be able to attach to the center member 226, in which case thesecond adhesive 112 b may not be necessary, and the adhesive may becovered with a cover sheet 309. And, the other side 331 of theperipheral edge 238 may be coated with an adhesive 112 to secure thebreathable foam pad 320 to the skin of the patient 82 that surrounds thewound 86, and this adhesive 112 may also be covered with a removablecover sheet 309.

Thus, the second anti-shear member side 274, upon contact with the skinof a patient 82, will not generate frictional forces and thus greatlyreduces and/or eliminates detrimental shearing forces being applied tothe wound 76.

FIG. 20 is a top plan view of the pad assembly 202 of the anti-shear pad200 in its assembled state, and FIG. 21 is a bottom plan view of the padassembly 202 of the anti-shear pad 200 in its assembled state.

The anti-shear pad 200, with the anti-shear member 270 adhered theretoand with the dressing 84 housed therein, is movable from an anti-shearpad un-flexed position 280 (FIG. 14A) to an anti-shear pad flexedposition 282 (FIGS. 22-24 and 26). The padding 40 from which the outerlayer 210 and the center member 226 are made provides them withflexibility, and the attached anti-shear member 270 is flexible. And,the cap 220 is flexible, but it offers resistance to flexing because ofthe plastic from which it is made. That is, the cap 220 is stiffer thanthe outer layer 210, the center member 226, and the anti-shear member270. Thus, when the anti-shear pad 200 is in the anti-shear pad flexedposition 282 the cap 220 is in the flexed cap position 224, but the cap220 biases against the outer layer 210 and the center member 226 in anattempt to return to the relaxed cap position 220. As shown in FIG. 22,when the anti-shear pad 200 is in the anti-sheer pad flexed position 282it has a generally convex shape and the anti-shear member 270 is convex.

FIG. 25 is a rear view of a patient 82 having a wound 86, and as shownthe patient has first and second buttocks 85 a, 85 b that form thebuttocks 89 of the patient 82. The wound 86 is in the vicinity where theskin 83 of the patient 82 overlies the sacral bone.

In use, the user first manually flexes the wound barrier device 199. Inparticular, the anti-shear pad 200 with attached anti-shear member 270is moved into the anti-shear pad flexed position 282 and moved into agap 90 defined by the buttocks 89, such that the anti-shear member 270abuts against each of the first and second buttocks 85 a, 85 b, and suchthat the anti-shear member opening 276 and the dressing 84 are alignedover the wound 86. The cap 220 exerts a cap biasing force 227 (asindicated in FIG. 16A by the arrow designated Y-Y) from a positioninternal to the anti-shear pad 200, and the cap biasing force istransmitted through the center member 226 and the anti-shear member 270and is applied against each of the first and second buttocks 85 a, 85 b,thus preventing the first and second buttocks 85 a, 85 b from closingtogether which is the natural tendency of the first and second buttocks85 a, 85 b. The anti-shear member 270 is held in place by the biasingforce yet at the same time allows for slippage against the skin 83 ofthe patient. Thus, deleterious frictional forces are not applied to thewound due to the presence of the anti-shear member 270. In addition, thefirst and second buttocks 85 a, 85 b are at all times biased apart andthe wound is therefore isolated from them. And drainage from the wound86 seeps into the dressing 84. FIG. 26 is a view showing the anti-shearpad 200 with anti-shear layer 270 after having been positioned in thebuttocks 89.

Removal of frictional forces being applied to the wound 83 by use of theanti-shear pad 200 and anti-shear member 270 may significantly enhancehealing time. In addition, the anti-shear pad 200 and anti-shear member270 can be used in healthy patients that are or will be bed ridden toprevent the formation wounds 86, for example ulcers.

It is pointed out that the outer layer 210, cap 220, center member 226,and anti-shear member 270 can have virtually any geometry and are notlimited to the cylindrical and rectangular shapes shown herein.

As shown in FIG. 27, in another preferred embodiment a kit 300 isprovided (and sold) wherein the kit 300 has a kit housing 302. Disposedinternal to the kit housing 302 is an assortment of wound barrier padcomponents 304 that are differently shaped. Indeed, the different shapesin which the wound barrier components can be embodied are virtuallylimitless. The internal structure and layering of the wound barrier padcomponents 304 can be embodied so as to be identical to the internalstructure of the wound barrier pad 20 and the anti-shear pad 200. Thekit may also include anti-shear members 270 wherein any adhesives 112are covered by one of the removable cover sheets 309. The kit 300provides the user with limitless options when treating a wound 86.

In any of the embodiments described above the padding 40 and dressing 84can be impregnated with silver particles.

FIG. 28 shows another embodiment for a wound care apparatus 398. Thewound care apparatus 398 includes a negative pressure generating device400. The negative pressure-generating device 400 is capable ofgenerating a vacuum and has a holding tank 402. The holding tank 402 isfor holding suctioned debris and fluid. In one of the preferredembodiments the suction developed is about 125 mm of negative pressure.The wound care apparatus 398 also includes a suction tube 404 withopposed first and second suction tube ends 406, 408. The first suctiontube end 406 is connected to the negative pressure generating device 400and is in fluid communication with the holding tank 402. The secondsuction tube end 408 is joined to a disc component 410 that defines adisc opening 412 such that suctioned fluids and debris flow through thedisc opening 412, into the suction tube 404 and into the holding tank402. The disc component 410 has opposed first and second disc sides 414,416 and the second disc side 416 is coated with an adhesive 112. Theadhesive 112 may have a removable disc cover sheet 418 that covers theadhesive 112. The removable disc cover sheet 418 is removed prior to useas indicated by the arrow designated T in FIG. 28.

The wound care apparatus 398 also includes a drape or sheet 420 as shownin FIGS. 29 and 30. The drape 420 has opposed first and second drapesides 422, 424 and a band of adhesive 426 is disposed on the seconddrape side 424. The band of adhesive 426 extends from the edge 426 ofdrape 420 a sufficient distance such that the drape 420 can be adheredto the patient with the band of adhesive 426, and the band of adhesive426 may be about 0.5 inches wide in one of the preferred embodiments. Aremovable sheet cover 428 is provided to cover the band of adhesive 426,with FIG. 30 showing the removable sheet cover 428 as it is being peeledoff the band of adhesive 426 (in the direction of arrow K). The drape420 also defines a drape opening 430 that allows fluid being suctionedto pass through the drape 420.

As shown in FIGS. 31 and 32 the wound care apparatus 398 also includes anegative pressure dressing 440 that is shown as having a circular shape.The negative pressure dressing 440 has plastic layer 441 made ofpolyurethane in one of the preferred embodiments, and has foam arms 442that extend radially from a center 444 of the negative pressure dressing440. The foam arms 442 serve as foam filled channels that allow thenegative pressure generated by the negative pressure generating device400 to be delivered to the wound being treated, and that allow fluids tobe drawn out of the wound due to the negative pressure. To accomplishthis the foam from which the foam arms 442 is made has perforations andmay be encased in a perforated film. The suctioned fluids flow throughthe suction tube 404 and flow into the holding tank 402. Negativepressure devices for use in connection with enhancing healing are wellknown to those having ordinary skill in the art and are therefore notdescribed in greater detail herein.

The wound care apparatus 398 also includes the wound barrier padsdescribed above. In particular, even though the negative pressure woundtreatments are known to accelerate the healing process of a wound, thepatient will still have considerable problems with pressure beingapplied to the vicinity of the wound. For example, when pressure isapplied to the body in the vicinity of the wound when the patient isrolled, when the patient is moved by a healthcare provider, or when thepatient moves or rolls under his or her own power. The use of theabove-described wound barrier pads in combination with the a negativepressure generated by the negative pressure generating device 400 willresult in enhanced healing because the stress and shear forces beingapplied to the wound are decreased.

In the embodiment shown in FIGS. 33-35 the wound care apparatus 398 alsoincludes the previously described rectangular shaped wound barrier pad50. The rectangular shaped wound barrier pad 50 is joined to the firstdrape side 422 with an adhesive 112. The suction tube 404 can passthrough a rectangular shaped wound barrier pad wall opening 430 or thesuction tube 404 can simple pass over the rectangular shaped woundbarrier pad 50. It is pointed out that in another preferred embodimentthe rectangular shaped wound barrier pad 50 is constructed without therectangular shaped base plate 72 for this application.

The wound care apparatus 398, in another preferred embodiment, includesthe previously described wound barrier pad 20 shown in FIGS. 1 and 2. Itis pointed out that in another preferred embodiment the wound barrierpad 20 is constructed without the base plate 36 for this application.

In another embodiment shown in FIGS. 36 and 36A, the wound careapparatus 398 includes a slightly modified wound barrier device 199 a.As shown in FIG. 36A, the outer lay 210 defines an outer layer opening210 a, the cap 220 defines a cap opening 220 a, the center member 226defines the center member opening 226, and the anti-shear member opening276 is defined in the anti-shear member 270, such that the suction tube404 is capable of passing through these openings. In another preferredembodiment, only the outer layer 210, the cap 220 and the center member226 described immediately above are present and are adhered to the firstdrape side 422. In either of the embodiments described immediately abovethe suction tube 404 is capable of extending though the slightlymodified wound barrier device 199 a.

Thus the present wound barrier pad 20, the rectangular shaped woundbarrier pad 50, the wound barrier device 199, and the wound careapparatus 398 and the embodiments described herein provide the patient82 and the health care professional with significantly improved ways totreat wounds, pressure ulcers and bedsores, and to prevent the onset ofbedsores. The wound barrier pad 20, the rectangular shaped wound barrierpad 50, the wound barrier device 199 are always in a fixed locationrelative to the wound. This is a significant improvement over presentwound treatment wherein bandages, dressing and wounds are subjected toundesirable pressure and shearing forces. In addition, the wound barrierpad 20, the rectangular shaped wound barrier pad 50, the wound barrierdevice 199, and the use of these in the wound care apparatus 398 canprevent the onset of wounds by using it at known pressure points wherepressure ulcers, bedsores and other wounds commonly occur. Similarly,the wound barrier pad 20, the rectangular shaped wound barrier pad 50,the wound barrier device 199, and the use of these in the wound careapparatus 398 may be used as soon as a healthcare provider detects theonset of a bedsore, and may be used before a wound develops or after awound develops.

It will be appreciated by those skilled in the art that while the woundbarrier pad 20, the rectangular shaped wound barrier pad 50, the woundbarrier device 199, and the use of these in the wound care apparatus 398have been described in connection with particular embodiments andexamples, the wound barrier pad 20, the rectangular shaped wound barrierpad 50, the wound barrier device 199, and the use of these in the woundcare apparatus 398 is not necessarily so limited and that otherexamples, uses, modifications, and departures from the embodiments,examples, and uses may be made without departing from the wound barrierpad 20, the rectangular shaped wound barrier pad 50, the wound barrierdevice 199, and the use of these in the wound care apparatus 398. Allthese embodiments are intended to be within the scope and spirit of theappended claims.

What is claimed:
 1. A wound barrier pad assembly for treating a wound ona patient, comprising: a) a wound barrier pad having a surroundinginternal wall defining an interior opening b) a disc-shaped componentdefining a central disc opening; c) a negative pressure generatingdevice capable of generating suction and having a suction tube withopposed first and second suction tube ends wherein the first suctiontube end is connected to the negative pressure generating device andwherein the second suction tube end is joined to said disc-shapedcomponent; d) a drape sheet defining a drape sheet opening, wherein saiddisc-shaped component is adhered to the drape sheet such that the drapesheet opening permits fluid communication through the central discopening and wherein the drape sheet is adapted to be adhered to apatient such that upon activation of the negative pressure generatingdevice fluid is suctioned from a wound through the suction tube; e) awound dressing positioned between said drape sheet and said patient; andf) wherein said wound barrier pad is adhered to the drape sheet suchthat the suction tube extends through the said interior opening and thedrape sheet opening, and said wound barrier pad is adhered to the drapesheet such that said interior opening is not positioned directly overthe wound, so as to relieve pressure from the wound site.
 2. The woundbarrier pad assembly according to claim 1, wherein said wound dressingcomprises foam arms that extend radially from the center of said wounddressing, wherein the foam arms provide fluid passages such that thefoam arms are in fluid communication with the negative pressuregenerating device.
 3. The wound barrier pad assembly according to claim1, further comprising a base plate having a base plate openingcorresponding to said interior opening.
 4. The wound barrier padassembly according to claim 1 wherein said wound barrier pad isrectangular shaped.
 5. The wound barrier pad assembly according to claim1 wherein said wound barrier pad is made from at least one of thefollowing materials: resilient materials, foams, neoprene, resilientfoams that return to their original shape after having been deformed,and fluids.
 6. The wound barrier pad assembly according to claim 1wherein the perimeter of said wound barrier pad is generally circular.7. The wound barrier pad assembly according to claim 1 wherein saidwound barrier pad is generally penannular, C-shaped, U-shaped, ordonut-shaped.